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68 Cards in this Set

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How much does the cost of clinical trials account for in percent?

80% to 90%

Pharmacology

Studies on how drug impacts the body and how the body interacts with the drug

Carcinogenicity

Identify cancer-inducting potential

Genotoxicitiy

Detect the drugs ability to cause an increase in genetic alterations

How many stages are required before approval?

4 Stages

How many drugs who make it to clinical make it to the market?



1 in 5

Which phase do drugs normally fall in?

Phase 2

Phase 4 of Clinical Trials

Safety and Efficacy


Designed to detect any rare or long term adverse effects

Phase 3 of Clinical Trials

Random and Controlled


See how effective it is compared to the "gold standard"


Costs the most money in this phase

Phase 2 of Clinical Trials

Efficacy= Capacity for having a beneficial change or therapeutic effect


Large number of people


Usually a drug will fail here


"Not work as planned" or Toxic effects

Phase 1 of Clinical Trials

Focus on safety


Healthy individuals


Small number of people


Figuring out dose ranging

What phase is it marketed?



After phase 3

What happens if you violate FDA?

Inspections and investigations


Warning letters


Recall


Withholding


Suspense


Clivil Lawsuit


Prosecution

Adulteration

Something that is not supposed to be there

Roles of the FDA

Regulate drugs&tests&biologics&labeling and post market surveillance



Misbranding

Something wrong with how it is labeled not correct

Mission of the FDA

To promote and protect


Ensure that food and medical products are safe and effective


Does not dictate medical practice or service


What role can plant biotechnology play in the world (applications)

Protect crops from disease


Increase the yield of food crops


Reduce the need for pesticides


Improve nutritional value of food


Make plant based medicines and vaccines


Provide a source for better and more sustainable biofuels


Help to protect the environment

What is considered natural and what is considered GM with regards to food?

Genetically modified (GM) foods are foods derived from organisms whose genetic material (DNA) has been modified in a way that does not occur naturally




Natural are foods that aren't altered in anyway shape or form

Which breeding methods are considered natural and can be labeled “natural” and which would be GM (unnatural)

GM breeding methods: gene splicing, agrobacterium tumefaciens, gene guns, antisense technology




Natural food breeding methods: Selective Breeding, Hybridization, Grafting, Mutation Breeding

Genetically modified?

The use of modern biotechnology techniques to change the DNA of an organism, such as a plant or animal

Transgenic Organisms?

An organism that has a gene from another species inserted into their genome

Recombinant Technology?

Involves inserting a gene from one organism into another though the use of a cloning vector

Recombinant DNA molecule?

The result of ligase is added to "glue" the sugar phosphate backbone together and seal the DNA fragments together

Such as a plasmid carrying the gene of interest



Why can transgenic organisms be useful to society?

Drugs


Food/Animals


Industrial Applications


Environmental Applications


Gene Therapy and Disease Research


Cloning Vector?

What you attach your gene to for transfer into the other organisms, plasmid is the most common.


Bacterphages are another type they are modified so that they transport DNA but don't cause disease.


Stemcell, Viruses and Bacterial artificial chromosomes and also be vectors

Characteristics of all stem cells that make them useful to doctors and researchers

They are pluripotent meaning that they can form any cell type (except placetra) Over 220 possible cell types

What does undifferentiated mean?

Biological cells that can differentiate into specialized cells and can divide (through mitosis) to produce more stem cells.


They are found in multicellular organisms.

What are the three kinds of stem cells?

Embryonic Stem Cells: Come from a five to six-day-old embryo. They have the potential to form virtually any type of cell found in the human body


Adult Stem Cells


iPS cells

What are pluripotent, Multipotent, Totipotent?

Pluripotent: cells that can form into any cell type expect placetra


Multipotent: More differentiated cells, but can form a number of different cell types within a cell line


Totipotent: They have the potential to develop into any cell found in the human body form a zygote

What are the myths and facts?

Myths:


Removing a mothers fetus from her


There are body parts on the embryo recognizing them as humans


It is illegal


Fact:


Never taken from the women's body and are created in the lab


They are blastocysts and nothing is recognizable


No option on either for or against by the government

Embryonic stem cell debate

Removing the embryonic stem cells from the blastocyst destroys the embryo


Destroying a living person because this blastocyst could potentially grow


Science is going to far

Advantages and Disadvantages of embryonic stem cells?

iPS cells?

Cells created from adult cells or adult cells that are reverted back to be embryonic like undifferentiated

Does the creation of iPS cells destroy an embryo?

no

Advances and Disadvantages of working with iPS cells?

Advantages:


Does not destroy or create


Same potential as embryonic stem cells


Less tissue rejection potentint since cells are from the patient's own body


Disadvantages:


Very little is known


needed stem cell research


same epigenetics patterns?


there is the potential for rejection

What are adult stem cells? Where are they found in the body?

Typically found among specialized or differentiated cells in a tissue or organ. They are more differentiated than Embryonic

Advantages and disadvantages of Adult Stem Cells?

Advantages:


Match the patient's own cells


Lack of converse


Most research


Disadvantages:


Exist in small numbers


Difficult to identify, isolatem purify and grow in the lab



Where are embryonic stem cells taken from?

early stage embryos called blastocyst

what is most important about a proteins ability to perform it's function?

Shape

What is the purpose of performing protein electrophoresis? (SDS-PAGE)

Determining the proteins before putting them into the gel


How many proteins are in my sample?


Molecular weight of the proteins?


Differences?


How pure is the sample?


How much protein?

What causes the proteins to move differently in the gel?

The amount of DNA

Why do we have to use a different gel?

The pores are way smaller in size

What does it mean when a gene is expressed or on?

It means that it is showing

How do genes code for proteins?

In translation though mRNA

What are proteins made up of and what type of bonds hold them together?

Chains of amino acids and Peptide bond

Analogy of how to make a protein

DNA is the cookbook


Ribosomes are the chefs


Directions for making the cake (proteins) have to get out of the nucleus and to the ribosomes


mRNA has to photocopy the recipe that goes to the cook


cook is ribosomes


tRNA brings the ingredients (amino acids) to the ribosome

What happens to the pre-mRNA before it can leave the cell to go to the ribosome?

The RNA needs to be modified in several ways


5' end needs to be capped


3' end has a poly A tail


Alternate Splicing Occur


How many genes do we have that code for how many proteins?

20,000 genes that code for approximately 100,000 proteins

What is splicing?

Before mRNA exits the nucleus it is cut and introns are removed leaving only exons

Alternate splicing?

A process where eons are removed from the pre mRNA


Allows for multiple proteins to be made

What direction is DNA read and what direction is it built?

3'-5' and 5'-3'

DNA CODE IS A TRIPLET

What is our epigenome?

is a pattern of the gene expression in a cell

What is the difference between our genome and our epigenome?

Our genome contains all the instructions for building and maintaining the parts of our body




Our epigenome is a pattern of the gene expression in a cell

Methylation and Acetylation

Methylation: Attach directly to the gene and usually turn off the gene


Acetylation: Loose = turn on tight= turn off

Which is fixed and which is environmental

Genome is fixed epigenome is environmental

Can epigenetic patterns be inherited? How?

Yes some epigenetic tags remain in place as genetic info passes from generation to generation epigenetic inheritance

What are some environmental impacts to our epigenome?

Diet, Toxins, Stress, Physical activity, hormones

What does it mean to silence a gene?

Occurs when a gene is turned off that would normally be expressed under normal conditions

What is RNAi and what does it stand for?

RNA interference and have control over which genes are active and how active they are

How could the use of the RNAi system help us treat disease? Which types?

It will help in immune response, identifying a gene function, medicine and bioengineering and it only helps with gene you need to turn off a gene

What triggers the RNAi system?

long-double stranded molecule

Why didn't all the worms experience a knockdown?

we gave them a protein that was developing so it only affected the kid ones

Importance of bioinformatics

Bioinformatics is an interdisciplinary field that develops and improves on methods for storing, retrieving, organizing and analyzing biological data. A major activity in bioinformatics is to develop software tools to generate useful biological knowledge.

Electropherogram?

is a plot of results from an analysis done by electrophoresis automatic sequencing

What is a DNA barcode? What are the lines?

A unique DNA sequence that identifies each living thing in the same way that the unique pattern of bars in a universal product code identifies each consumer product


The lines are your DNA

When you BLAST a sequence what are you doing?

You will identify known sequence in the database